Z-0703-2020 Class II Terminated
FDA device recall Z-0703-2020 was initiated by Teleflex Medical on October 30, 2019 and is designated Class II. Reason for recall: The tracheal and brochial swivel connectors are incorrectly labeled. The recall status is terminated (terminated September 30, 2021). Affected quantity: 53 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- October 30, 2019
- Termination Date
- September 30, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 53 units
Product Description
HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
Reason for Recall
The tracheal and brochial swivel connectors are incorrectly labeled.
Distribution Pattern
US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.
Code Information
Catalog: 5-16135; Manufacturing Lot: 73G1600257